Agency classClass IIOur severity:High FDA (Devices)·Z-0781-2019·Announced 2019-02-06

Siemens Atellica Analyzer Software Recall for Multiple System Issues

Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing systems.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Atellica Solution System software, specifically versions 1.14.2 and lower. The recall involves the Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica CH 930 Analyzer, and Atellica Sample Handler Prime. These systems are used for the qualitative and quantitative analysis of various body fluids for clinical use.

The recall was initiated because multiple issues were identified in the software. The source text does not specify the exact nature of these issues or report any specific injuries or illnesses. The affected units were distributed worldwide, including the United States and numerous international locations such as Australia, Canada, and countries across Europe, Asia, and South America.

Healthcare facilities and users of these diagnostic systems should contact Siemens Healthcare Diagnostics for further instructions on how to address the software issues. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: software-defect
mis-diagnosis
Affected units: 264

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Software in V 1.14.2 and lower.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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